Testing GS-9911 with or without an antibody for adults with solid tumors
A Phase 1 Study to Evaluate the Safety and Tolerability of GS-9911 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
This study is testing a new treatment called GS-9911, alone and with another drug, to see if it helps adults with advanced solid tumors feel better and stay safe.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gilead Sciences Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone |
| Locations | 6 sites (New Haven, Connecticut and 5 other locations) |
| Trial ID | NCT06082960 on ClinicalTrials.gov |
What this trial studies
This first-in-human study aims to evaluate the safety and dosing of GS-9911, both as a standalone treatment and in combination with an anti-PD-1 monoclonal antibody, in adults with advanced solid tumors. The study will assess the safety and tolerability of these treatments, identify the maximum tolerated dose, and determine the recommended dose for further studies. Participants will be closely monitored for their response to the treatment and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced solid tumors who have exhausted all standard treatment options or are intolerant to them.
Not a fit: Patients with early-stage solid tumors or those who have not yet received standard treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.
How similar studies have performed: Other studies involving immune checkpoint inhibitors have shown promising results, suggesting potential for success with this novel combination approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Parts A, C, and D: * Participants with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit * Part B: * Participants whose cancer previously derived clinical benefit from immune checkpoint inhibitors, or who have advanced solid tumor types for which immune checkpoint inhibitors are considered the standard of care and who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Evaluable (Part A) or measurable (Parts B, C, and D) disease as per Response Criteria Evaluation in Solid Tumors (RECIST) v1.1 criteria * Adequate organ functions * Tissue requirement: * Parts A-D: must be willing to provide baseline tumor tissue prior to enrollment * Part A backfill cohorts: a biopsy should be obtained prior to treatment and on treatment, if safely feasible * Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception Exclusion Criteria: * Positive serum pregnancy test or lactating female * History of intolerance, hypersensitivity, or treatment discontinuation due to life- threatening immune-related adverse events on prior immunotherapy * Receipt of the therapies listed below within the specified timeframe prior to planned Cycle 1 Day 1 including: major surgery (\< 4 weeks), immunotherapy or biologic therapy (\< 28 days), chemotherapy (\< 21 days), targeted small molecule therapy (\<14 days or 5 half-lives, whichever is sooner), hormonal or other adjunctive therapy (\< 14 days), radiation therapy (\< 21 days), live vaccine (\< 28 days) * Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation * Diagnosis of immunodeficiency, or requires systemic corticosteroids (\> 10 mg of prednisone daily, or equivalent) * History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study drug * History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, drug-induced pneumonitis, or severe radiation pneumonitis (excluding localized radiation pneumonitis) * Active second malignancy. Note: individuals with a history of malignancy that have been completed treated, with no evidence of active cancer for 2 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Symptomatic cardiovascular disease * Active serious infection requiring ongoing treatment * Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV. * Symptomatic ascites or pleural effusion Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
New Haven, Connecticut and 5 other locations
- Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- NEXT Oncology — San Antonio, Texas, United States (Recruiting)
- South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States (Recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
- University Health Network, Princess Margaret Cancer Centre — Toronto, Canada (Recruiting)
Study contacts
- Study coordinator: Gilead Clinical Study Information Center
- Email: GileadClinicalTrials@gilead.com
- Phone: 1-833-445-3230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.